Sampling apparatus



Aug. 26, 1958 R. F. MCGREW ET AL 2,848,999

SAMPLING APPARATUS Filed Nov. 13, 1952 2 Sheets-Sheet 1 I JOHN nos A INVENTOAs A A Mi/Zon L.Turner Robert 1". Grew R. F. M G REW ETAL Aug. 26, 1958 SAMPLING APPARATUS 2 Shee'ts-Sheet 2 Filed Nov. 13, 1952 l l Ill INVENTORS lil /on Z. Yiu'rzer en! E M Grew Rob 2,848,999 Patented Aug. 26, 1958 SAMPLING APPARATUES Robert F. McGrew, Waulregan, Ill., and Milton L.

Turner, Towson, Md, assignors to Abbott Laboratories, tlhicago, Ill, a corporation of l'liinois Application November 13, 1952, Serial No. 320,332 14 Claims. (Cl. 128-276) This invention relates generally to fluid sampling apparatus and more particularly to a disposable, unitary, plastic blood sampling unit.

Included among the objects and advantages of the present invention is a disposable syringe for collecting a sample of blood, which syringe also functions as a dropper, a centrifuge tube and a test tube. Further, the device is a sterilized unit package adapted for one and only one blood sample.

The general apparatus used heretofore for blood sampling, consisted mainly of a glass hypodermic syringe, and several test tubes including centrifuge tubes, test tube racks, medicine droppers, etc. The glass syringe normally had a detachable hypodermic needle, and since the two were used to draw blood from the patient, they had to be autoclaved with steam or boiled in water to insure sterility. Under the constant temperature changes from such sterilization, the glass syringes were only usable for about 20 samplings. Furthermore, the extensive handling of the syringes and tubes for washing, sterilizing, and so forth, including a large percentage of breakages, made the procedure unduly expensive.

A major disadvantage of the common blood sampling method is the transmittance of viral diseases, such as hepatitis, from patient to patient due to faulty sterilization. Few medical offices or laboratories are equipped with high pressure steam autoclaves capable of giving adequate sterilization of the equipment to prevent the transmitting of such viral diseases.

Generally, the present invention comprises a trans-- parent, or at least a translucent, resilient plastic tube having one closed end, and an outlet at the opposite end, and means on the outlet available for directing a blood sample into the tube.

The device of the invention and the mode of operation thereof may be more fully understood by reference to the following description thereof, and the accompanying drawings, inwhich:

Figure 1 is a vertical sectional view of a device according to the invention;

Figure 2 is a plan view of the device shown in Figure 1;

Figure 3 is an elevation of a device according to the invention in one operative position;

Figure 4 is a side elevation view of modified form of the device;

Figure 5 is an enlarged vertical sectional view along the lines 5-45 in Figure 4;

Figure 5a is a plan view of the device shown in Figure 5 with the cap removed;

Figure 6 is an enlarged fragmentary vertical sectional view of a still further modification of the device shown in Figure 5.

Figure 6a is a plan View of the device shown in Figure 6; and

Figure 7 is a side elevation view of the device shown in Figure 4 in one operative position.

The blood sampling device illustrated in Figures l and 3 comprises a tube body it) of resilient, clear 0 then removed, and a hypodermic needle extruded plastic, having walls sufliciently strong to resume normal shape after being distorted. One end of the tube 10 is closed by a cylindrical plug 12, sealed therein by heat or solvent. The opposite end of the tube 16 is closed by cap 14 which is likewise sealed onto the tube. The cap 14 tapers to a small outlet neck 15, into which is sealed a short section of resilient extruded plastic tubing 16. A tubing clamp 24 is placed on the tubing 16, and a needle adapterlS is sealed on the outer end of the tubing 16. A small tubular cap 20 fits over the needle adapter, and'the end thereof is closed by a piece of sterile cotton 22. The tubing clamp 24 as shown is a thin piece of metal having a tapered slot 26 available for pinching the tube.

After assembly, the device is sterilized and packaged in a suitable container for shipment to point of use. In operation, the sampling device is bent or folded double, as indicated in the configuration of Figure 3, and the tubing clamp 24 is moved to force the tubing into the narrow end of the slot 26, closing the tubing. in the distorted shape, the volume of the tube 10 is materially decreased. Closing the outlet tubing while the volume is thus decreased and releasing the main tube leaves a partial vacuum in the sampling device. The cap 20 is 28 is attached to the needle adapter 18. The needle is then inserted into a patients vein, and the tubing clamp is slowly moved to open position. The partial vacuum of the device assists in drawing blood from the patients vein into the sampler.

Alternatively, without any pinch clamp, the user can merely double up the tube, as indicated in Figure 3, and hold it inside his hand, collapsed by manual pressure, while the needle is inserted. Then it is only necessary to release the pressure on the body ill to initiate the withdrawal of blood.

When suflicient blood has been drawn into the sampler, the pinch clamp is again moved to closed position, and the needle withdrawn from the patients vein. The needle is disassembled from the device, and the device may be sent to the laboratory for blood testing.

Where required, the clamp in the device may be opened, the sampling unit inverted, and by gently squeezing the main tube it), drops of blood may be dispensed where desired, as for samples for various blood tests. The Whole unit may be placed in a centrifuge for separating the blood cells from the plasma. With or without centrifuging, the top may be severed along line 1-1, leaving a small plastic test tube which will stand upright, due to the square base formed by the plug 12. A small weight 23 may be embedded in the bottom of plug 12 to increase stability.

Especially in sizes up to 20 ml., with commercial plastic tubing of an inside diameter of the order of mag nitude of /8 of an inch and a wall thickness of .05 of an inch, a simple tube has enough mechanical strength to exert a substantial suction and expedite the flow of blood into the device, so that the time required to take the sample can be substantially reduced.

in a large hospital where many samples need to be taken, the devices can be packed in individual boxes or in sets of a dozen or more, separated by paper partitions, each device carrying an identification tab affixed thereto. Such a tab may be a mere strip of paper 19, with a little adhesive on one side, wrapped around the body Ill near the top, with a portion projecting as indicated at 21. For packaging, the projecting portion 21 can be conveniently wrapped around the body.

Thus the operator pulls one of the devices out of the carton, writes on the tab such identifying indicia as may be desired, fills the device with the patients blood and the filled container with the pinch clamp 24. The

container is then a non-breakable, completely identified unit, which can be put back in the original package from which it is withdrawn or accumulated in a pocket or basket and delivered to the laboratory, fully identified and ready for processing.

In the laboratory, each of the devices can be put into a centrifuge without removing the tab, centrifuged, cut off along the line l1 and placed upright on a laboratory bench, where it will stand firmly while the laboratory worker makes any desired tests and inspection and fills out a report for the use of the medical staff.

The modified form of the invention shown in Figures 4 through 7 and designated generally by B comprise a main tube body of resilient, plastic tubing such as polyethylene plastic, having walls sufficiently transparent to permit observation of the interior thereof and sufficiently strong to resume normal shape after being distorted. One end of the tube body is normally closed by heat or solvent sealing the walls of the tube body together along one extremity thereof forming a transverse seal 31 at one end of the tube body. The opposite end of the tube is partially closed by an end closure member 32 having the circumferential configuration of the tube body and which may be heat or solvent sealed in the open end of the tube body but which is preferably molded integrally therewith, thereby forming an integral part of the tube body. The end closure member 32 has an axially alined tube or hypodermic needle adapter 33 integrally formed thereon which is tapered to the approximate dimensions of a standard luer taper (0.170 in. diameter at A" from the tip and tapering at 3 26 to the larger end) for attaching a cannula 34 of a hypodermic needle 35 thereto and which serves as a means for conducting liquids into the interior of the said tube body. The taper of the adapter 33 is preferably made to provide a slight interference with the needle hub in order to hold the hub more securely.

Preferably on the upper surface of the end closure member 32 are disposed two segmentally shaped blocks 36 which serve as a means for locking the hypodermic needle in place and which are preferably molded integrally with the end closure member symmetrically disposed on opposite sides of the needle adapter 33. The oppositely disposed inner surface of the segmentally shaped blocks are under cut slightly as at 37 to receive and frictionally engage the hub 38 of the hypodermic needle 35, thereby locking the needle in place on the end of the tube. If desired, other means for locking the needle hub on the adapter 33' may be employed or the locking means may be omitted altogether. Preferably, also on the upper surface of the end closure member 32 medially on the upper surface and the segmentally shaped sections 36 (Figure a) or between the outer ends of, the segmentally shaped sections 36' (Figure 6a) are mounted preferably integrally there with small sections of plastic 39 and 39, re-

spectively which are either readily penetrable or have an opening transversely therethrough for receiving a pin or other fastening means for securing the tube to the patients apparel. If preferred, however, the means for pinning or securing the tube to the patients apparel may be aflixed to the lower end of the tube body, as by forming a tab extending longitudinally from the sealed section at the lower end.

The needle adapter 33 is normally protected by means of a protective sealing cap 40 when the hypodermic needle is not positioned on the needle adapter 33. The cap member 40 is preferably comprised of a rigid generally cylindrical main body section 41 which can be readily grasped by the operator. The upper portion of the cap 40 is preferably frustoconical in shape having conical walls 42 thereof designed to fit the taper of a standard conical centrifuge tube and the flat upper surface 43 thereof designed alternatively to be accommodated by the flat bottomed centrifuge tube of the standard centrifuge. Projecting outwardly from the lower surface of the cylindrical body section of the cap member 40 is an axially alined cylindrical plug 44 having an outside diameter substantially the same as the inside diameter of the axial passage through the needle adapter 33 and having a length less than that of the said needle adapter 33. Also projecting from the lower surface of the cylindrical body 41 of the cap and disposed concentrically about the axial plug 44 is an outer cylindrical sleeve 45 having an interior diameter slightly greater than the exterior diameter of the outer end 46 of the tapered needle adapter 33 and an interior diameter slightly less than the exterior diameter of the inner end 47 of the said tapered needle adapter 33.

When the sealing cap 40 is seated on the needle adapter 33 the axial plug 44 fits within the passage through the needle adapter 33 and forms a primary seal inside the said adapter. Simultaneously, as the plug 40 seals the interior of the passage through the adapter 33, the cylindrical sleeve 45 frictionally engages the outside of the tapered needle adapter 33 and forms a secondary seal on the outer surface of the tapered needle adapter 33. When the sealing cap 40 is fully seated and the primary and secondary seals are formed, the cap 40 is securely held in position on the needle adapter 33 and will not become accidentally disengaged therefrom during the vigorous handling or when the tubes are centrifuged during serological examination of a blood sample. The modified forms of the blood sampling tube heretofore described and shown in Figures 4 through 7 are sterilized and packaged in a suitable container in the usual manner.

In using the latter embodiments of the invention to collect a sample of blood, the cap member 40 is removed and the standard hypodermic needle 35 with luer taper is locked in position on the needle adapter 33 in the normal manner by rotating the hub 38 of the needle about after it is fully seated on the adapter 33. After the hypodermic needle has been locked in position and immediately prior to collecting the blood sample the lower half of the tube is folded upwardly and the walls of the tube compressed between the operators thumb and forefinger, thereby forcing a substantial amount of the air out of the tube and when the pressure on the tube is released creating a partial vacuum within the tube. The hypodermic needle cannula 34 is then inserted into the patients vein while the tube is held in the folded and compressed position. When the tube is released and allowed to re turn to its normal expanded position, the partial vacuum created within the tubeassists greatly in collecting the blood sample and reduces the time required for collection we minimum. When a sutficient volume of blood has been collected as indicated by inspection or markings on the side of the tube, the needle is removed from the patients vein in the usual manner and the hypodermic needle 35 removed from the needle adapter The sealing cap 40 is immediately press fitted onto the needle adapter 33. thereby sealing the tube and securing the cap in position. While unnecessary when proper interferences are provided, the lower end of the sleeve 45 of the cap 4-0 can he provided with projections such as those of the lower end of the hub of the hypodermic needle so that the cap can be locked in place in the same manner the needle is locked in place. In each of the foregoing operations, the manipulation of the tube is facilitated by the several ridges 43 extending circumferentially about the tube adjacent the top and bottom thereof. If desired, indicia may also be placed on the walls of the tube to indicate the volume of liquid sample collected. Also extending longitudinally of the tube body are two strengthening ribs 49 on each side of the tube body which serve to prevent cracking of the tube body when flexing and to increase the resiliency of the tube body.

When only a few drops of blood are desired for testing, the sealing cap 40 of the blood sampling tube B is removed and the tube body squeeze until the desired amount of blood is forced outwardly through the passage in the needle adapter 33. The tube B can be rescaled by firmly reseating the cap 40 on the adapter 33. The tube B can be placed in a standard centrifuge having either the flat bottomed or conically tapered tube holders with the sealing cap 40 extending downwardly and the desired separation of the blood achieved without unsealing the tube and exposing the contents therof. To examine the separated fractions of blood, it is unnecessary to invert the tube or to remove the cap member 40. Thus, access to the contents of the tube can be most conveniently had without mixing the separated fractions by cutting through the walls of the tube along a line spaced slightly inwardly of the transverse seal 31 at the lower edge of the tube. By cutting across the tube in the above manner a container similar to the standard test tube is obtained which facilitates the subsequent examination of the blood fractions.

An additional feature embodied in the latter modified form of the invention which greatly increases the useful ness of the blood sampling tube is the means provided for securing a tube to the apparel of the patient. Thus, for example, it is possible for an emergency aid station attendant to obtain a sample of a patients blood in the plastic tube and attach the sealed tube to the wounded patients clothing by means of a pin or the like so that when the wounded patient arrives at the base hospital an attendant will be immediately able to make the necessary tests on the patients blood without delay resulting in further injury to the patient. The said means provided are preferably symmetrically disposed and balanced in order to facilitate using the tubes in a centrifuge.

This application is a continuation-in-part of our copending U. S. patent application Serial No. 208,561, filed January 30, 1951, now Patent No. 2,655,152.

Others may readily adapt the invention for use under various conditions of service, by employing one or more of the novel features disclosed or equivalents thereof. As at present advised with respect to the apparent scope of our invention, we desire to claim the following subject matter.

We claim:

1. A fluid sampling device comprising a section of deformable resilient tubing having one end closed and the other end supporting an end closure member permanently secured therewith and having extending outwardly therefrom a tube of substantially smaller diameter than the said resilient tubing having an unobstructed axial passage therethrough directly communicating with the interior of the said tubing, said tube having means for detachably securing on one end thereof a hub of a hypodermic needle, and cover means enclosing the said means for accommodating the hub of a hypodermic needle and for sealing the said tube to prevent contamination of the interior of the said tubing and dissipation of the contents thereof which detachably engages the said means for securing the hub of a hypodermic needle, said sampling device exerting a substantial suction when expanding after being deformed and thereby assisting the flow of fluidinto the said device.

2. A fluid sampling device comprising a section of deformable resilient tubing having one end closed and the other end supporting an end closure member permanently secured therewith and having extending outwardly therefrom a tube of substantially smaller diameter than the said resilient tubing having an unobstructed axial passage therethrough directly communicating with the interior of the said tubing, said tube having means for detachably securing on one end thereof a hub of a hypodermic needle, and a protective cover inserted over the end of the said tube which detachably engages the said means for detachably securing the hypodermic needle hub, said resilient tubing exerting a substantial suction when expanding after being deformed, thereby assisting the flow of fluid into the said device.

3. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having the walls thereof at one end sealed together closing the said end, an integral end closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubiug integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough which affords unobstructed access to the interior of the said tubing, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the said short tube sealing the end thereof which engages said tapered end of said tube, said sampling device exerting substantial suction when expanding after being deformed, thereby assisting the flow of blood into the said device.

4. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having the walls thereof at one end sealed together closing the said end, an integralend closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough aifording access to the interior of the said tubing, said end'closure means having means spaced outwardly from the said tube for securing the said fluid sampling device to an inanimate object, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the said tube sealing the end thereof which engages said tapered end of said tube, said sampling device exerting a substantial suction when expanding after being deformed, thereby assisting the flow of blood into the said device.

5. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having the walls thereof at one end sealed together closing the said end, an integral end closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough which aifords access to the interior of the said tubing, said end closure means having means spaced outwardly from the said short tube for engaging the hub of a hypodermic needle, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the said short tube sealing the end thereof which engages the said tapered end of said short tube, said sampling device exerting substantial suction expanding after being deformed, thereby assisting the flow of blood into the said device.

6. A blood sampling device comprisin a section of a substantially cylindrical deformable resilient tubing having the walls thereof at one end sealed together closing the said end, an integral end closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough which affords access to the interior of the said tubing, said end closure means having at least one outwardly projecting tab which facilitates securing the said sampling device to a patients clothing, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the said short tube sealing the end thereof which engages the said tapered end of said short tube, said sampling device exerting substantial suction when expanding after being deformed, thereby assisting the flow of blood into the said device.

7. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having the Walls thereof at one end sealed together closing the said end, an end integral closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough which affords access to the interior of the said tubing, said end closure means being substantially rigid and resistant to deformation when the walls of the said tubing are deformed, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the end of said short tube sealing the end thereof which engages the said tapered end of said short tube, said sampling device exerting substantial suction when expanding after being deformed, thereby assisting the flow of biood into the said device.

8. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having the walls thereof at one end sealed together closing the said end, an integral end closure means at the other end of said tube having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial pasage therethrough which affords access to the interior of the said tubing, said short tube having the outer end thereof tapered to accommodate the hub of a hypodermic needle, and a removable protective cover over the end of said short tube sealing the end thereof which engages the said tapered end of said short tube, said cover having means for being s cured in sealed position on the said short tube protecting the said tapered end and the interior of said tubing against contamination, said sampling device exerting a substantial suction when expanding after being deformed, thereby assisting the flow of blood into the said device.

9. A blood sampling device comprising a section of a. substantially cylindrical deformable resilient tubing having the walls thereof at one endsealed together closing the said end, an integral end closure means at the other end'of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom, said tube having an unobstructed axial passage therethrough which affords access to the interior of the said tubing, said short tube having the outer end thereof tapered for detachably securing thereto the hub of a hypodermic needle, and a removable protective cover over the said short tube sealing the end thereof which engages the said tapered end of said short tube, said protective cover having a plane supporting surface at the outer end thereof suitable for inserting the device in an inverted position into a tube holder of a standard centrifuge.

10. A blood sampling and dispensing device comprising a length of substantially transparent cylindrical tubing of resilient plastic material, the said tubing having the wal s at one end thereof sealed together to form a transverse seal closing the end of the said tubing, the other end of said tubing partially closed by an integral transverse end closure means integral therewith and having extending therethrough a short relatively rigid non-deformable tube in alignment with the axis of the said tubing which extends outwardly therefrom, said tube having an unobstructed axial passage communicating with the interior of said tubing and having the end thereof tapered to de tachably retain on the outer surface thereof the hub of a hypodermic needle, said tube being the only inlet and outlet for the said device, and a protective closure member cxtending over the end of said tube sealing the end of the said tube having means for engaging the inside and outer tapered lateral surfaces of the said tube simultaneously, said tubing being sufficiently resilient to return to its original shape after being compressed, thereby exerting a substantial suction when expanding to assist the flow of fiuid'into the interior thereof.

11'. A fluid sampling device comprising a section of deformable resilient tubing having one end closed and the other end supporting an end closure member having a small diameter tubular member extending outwardly from said resilient tubing forming a restricted discharge opening, said tubular member having an unobstructed axial passage communicating directly wtih the interior of the said resilient tubing and also having means at the outer end thereof for detachably securing thereto a hub of a hypodermic needle, and cover means removably engaging the said means for accommodating the hub of a hypodermic needle and sealing the end of said tube to prevent contamination of the interior of the said tubing, said sampling device exerting a substantial suction when expanding after being deformed and thereby assisting the flow of fluid into the said device.

12. A blood sampling device comprising a section of a substantially cylindrical deformable resilient tubing having-the walls thereof at one end sealed together closing the said end, an integral end closure means at the other end of said tubing having a relatively short rigid tube of substantially smaller diameter than the said resilient tubing integral therewith and extending outwardly therefrom which affords unobstructedaccess to the interior of the said tubing, said short tube having the outer end thereof tapered to accommodate the hub of a hypodermic needle, and a removable protective cover over the said short tube sealing the end thereof, said protective cover having a conically tapered lateral outer surface and a flat outer end surface providing an end structure suitable for inserting in an inverted position into the conically tapered tube holder of a standard centrifuge and supporting the said sampling device in inverted sealed position.

13. In a liquid container structure having a substantially tubular body section and an integral short rigid tube of substantially smaller diameter extending outwardly therefrom at one end providing the only inlet thereto and being suitable for detachably engaging the hub of a hypodermic' needle, the improvement comprising a closure cap comprising a substantially rigid body section having an axial plug extending outwardly from the inner surface thereof for forming a sealing engagement with the interior of the said rigid tube and a cylindrical sleeve member spaced outwardly from and concentrically with the said plug also extending from the said inner surface of the body section, the outer end of said body section being provided with a conically tapered lateral surface and a flat outer end surface; whereby the said container is adapted to being inserted intothe conically tapered tube holder of astandard centrifuge in an inverted sealed position.

14. A closure cap substantially as in claim 13 wherein the cylindrical sleeve member is provided at the lower end thereof with outwardly extending projections for engaging the said container to retain the said cap on the said rigid tube.

References Cited in the file of this patent UNITED STATES PATENTS 2,158,593 Scrimge ur May 16, 1939 2,526,365 Jorgensen Oct. 17, 1950 2,597,715 Erikson May 20, 1952 2,625,157 Lockhart' Jan. 13, 1953 2,636,493 Lockhart Apr. 28, 1953 2,642,064 Lawshe June 16, 1953 FOREIGN PATENTS 573,611 Great Britain Nov. 28, 1945 

